12 / 36
COMBI-AD Primary Analysis: RFS and OS
Median follow-up: 2.8 years
12
a
Prespecified significance boundary (
P
= .000019); next interim analysis planned when 50% of events have occurred.
NR, not reached.
Long GV, et al.
N Engl J Med
. 2017 Sep 10. [Epub ahead of print].
Relapse-Free Survival
(primary endpoint)
Overall Survival
438 413
405 392 382 373 355 336 325 299 282 276 263 257 233 202 194 147 116 110 66 52 42 19 7 2 0
432 387 322 280 263 243 219 203 198 185 178 175 168 166 158 141 138 106 87 86 50 33 30 9 3 0 0
Months From Randomisation
No. at Risk
0
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52
Proportion Alive and Relapse Free
1 y, 88%
2 y, 67%
3 y, 58%
1 y, 56%
2 y, 44% 3 y, 39%
438 426 416 414 408 401 395 387 381 376 370 366 362 352 328 301 291 233 180 164 105 82 67 28 12 5 0
432 425 415 410 401 386 378 362 346 337 328 323 308 303 284 269 252 202 164 152 94 64 51 17 7 1 0
0
0
0
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54
Proportion Alive
1 y, 97%
2 y, 91%
3 y, 86%
1 y, 94%
2 y, 83%
3 y, 77%
Months From Randomisation
No. at Risk
Group
Events, n (%) Median (95% CI), mo HR (95% CI)
Dabrafenib plus
trametinib
60 (14)
NR (NR-NR)
0.57
(0.42-0.79);
P
= .0006
a
Placebo
93 (22)
NR (NR-NR)
Group
Events, n (%) Median (95% CI), mo HR (95% CI)
Dabrafenib plus
trametinib
166 (38)
NR (44.5-NR)
0.47
(0.39-0.58);
P
< .001
Placebo
248 (57)
16.6 (12.7-22.1)
PRESENTED BY GV LONG AT WCM/SMR 2017
Data cutoff: 30 June 2017.